DOCUMENTATION OF FINAL APPROVAL AND VERIFICATION · PATIENT NAME Victoza® may be appropriate for:...

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PATIENT NAME Victoza ® may be appropriate for: Considering the glycemic and cardiovascular profile, Victoza ® is the only therapy approved to improve glycemic control and reduce the risk of major adverse cardiovascular events (MACE) a : CV death Nonfatal MI Nonfatal stroke SIGNATURE As the patient’s cardiologist, I would like to recommend Victoza ® as a treatment option for this patient. CV=cardiovascular; MI=myocardial infarction. a Major adverse CV events (MACE) comprised of CV death, nonfatal MI, and nonfatal stroke. Indications Victoza ® (liraglutide) injection 1.2 mg or 1.8 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established CV disease. Limitations of Use • Victoza ® is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis. • Concurrent use with prandial insulin has not been studied. Note to patient Please bring this letter with you to your next regularly scheduled appointment with the physician managing your diabetes. It will help to start the conversation with him/her about your treatment options. Please read the attached educational information about Victoza ® . Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza ® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. • Victoza ® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Victoza ® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Victoza ® . Please see additional Important Safety Information, including Boxed Warning, throughout this brochure. Please see accompanying Prescribing Information. Victoza ® is a registered trademark of Novo Nordisk A/S. Novo Nordisk ® is a registered trademark of Novo Nordisk A/S. © 2017 Novo Nordisk Printed in the U.S.A. USA17VIM02789 November 2017

Transcript of DOCUMENTATION OF FINAL APPROVAL AND VERIFICATION · PATIENT NAME Victoza® may be appropriate for:...

Page 1: DOCUMENTATION OF FINAL APPROVAL AND VERIFICATION · PATIENT NAME Victoza® may be appropriate for: Considering the glycemic and cardiovascular profile, Victoza® is the only therapy

PATIENT NAME

Victoza® may be appropriate for:Considering the glycemic and cardiovascular profile,

Victoza® is the only therapy approved to improve glycemic control and reduce the risk of major adverse cardiovascular events (MACE)a:

• CV death • Nonfatal MI • Nonfatal stroke

SIGNATURE

As the patient’s cardiologist, I would like to recommend Victoza® as a treatment option for this patient.

CV=cardiovascular; MI=myocardial infarction.aMajor adverse CV events (MACE) comprised of CV death, nonfatal MI, and nonfatal stroke.

Indications Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established CV disease.

Limitations of Use• Victoza® is not a substitute for insulin and should not be used in patients with type 1 diabetes

mellitus or diabetic ketoacidosis.• Concurrent use with prandial insulin has not been studied.

Note to patient

Please bring this letter with you to your next regularly scheduled appointment with the physician managing your diabetes. It will help to start the conversation with him/her about your treatment options. Please read the attached educational information about Victoza®.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS• Liraglutide causes dose-dependent and treatment-duration-dependent

thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

• Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Victoza® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Victoza®.

Please see additional Important Safety Information, including Boxed Warning, throughout this brochure. Please see accompanying Prescribing Information.

Victoza® is a registered trademark of Novo Nordisk A/S.Novo Nordisk® is a registered trademark of Novo Nordisk A/S.© 2017 Novo Nordisk Printed in the U.S.A. USA17VIM02789 November 2017